NCT07384117

Long-term Outcomes of Urethral and Uterosacral Ligament Plication

Long-term Outcomes of Urethral Ligament Plication and Uterosacral Ligament Plication: a Multicenter Prospective Study

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: Alev Esercan · Other Government
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The aim of this study is to determine the long-term success and outcomes of urethral ligament plication surgeries in patients with stress incontinence and uterosacral ligament plication surgeries in patients with urge incontinence.

Detailed description

For patients experiencing stress urinary incontinence during coughing and sneezing, which increases the intra-abdominal pressure, urethral ligament (pubourethral ligament/external urethral ligament) surgery will be performed. For patients with urge incontinence (inability to hold urine immediately) and posterior compartment syndrome (nocturia, constipation/fecal incontinence), uterosacral ligament plication surgery will be performed. For patients with both types of urinary incontinence, both surgeries will be performed, and the 2-year postoperative results will be evaluated. This study will be a double-blind, prospective experimental study. Patients with stress urinary incontinence will undergo preoperative examination using an integral theory questionnaire to assess their symptoms and complaints anatomically and physiologically. The surgeon will always be the same person (Esercan A), and patients will be called for a follow-up examination two years after surgery (routine postoperative check-ups will be performed, but our study will focus on the results at the end of the second year). This examination will be conducted by the same surgeon, different from those who performed the surgery and published the findings, and the integral theory questionnaire will be used again for evaluation. Integral theory was defined in the literature by Professor Peter Emanuel Papa Petros from our research team, and he also provided the integral theory questionnaire. We already use this questionnaire in routine practice. Additionally, any postoperative complications will be recorded in detail.

Conditions

• Incontinence Stress
• Incontinence, Urge

Interventions

Type	Name	Description
PROCEDURE	uterosacral ligament plication, urethral ligament plication	Urethral ligament plication: With an 18-inch French Foley catheter inserted, a vertical incision of approximately 3 cm is made in the sulcus of the anterior-lateral vaginal wall, 2 cm laterally on each side of the midline, ensuring the urethral meatus remains midline. The external urethral ligaments are located inferolateral to the urethra on both sides, the urethral portion of the pubourethral ligament (PUL) is located midline, and the lateral portion of the PUL is located laterally. Using 2-0 polyester sutures, the ligaments are sutured separately on both sides to form a loop. The incised anterior vaginal tissue is then closed individually with 2-0 rapid polyglactin sutures. Uterosacral ligament plication: A 18F Foley catheter inserted, in the lithotomy position; the posterior cervical lip is grasped with a tenaculum, and elevated outwards and upwards. Leaving rectovaginal fascia and rectum posterior; suturing the both uterosacral ligament by 2-0 polyester sutures in the midline.

Timeline

• Start date: 2026-01-01
• Primary completion: 2026-03-01
• Completion: 2026-03-10
• First posted: 2026-02-03
• Last updated: 2026-02-03

Locations

1 site across 1 country: Turkey (Türkiye)